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日本のポイントオブケア（POC）診断市場：2025年～2033年

Japan Point-of-Care Diagnostics Market - 2025-2033

出版日
ページ情報
英文 126 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=143.57円
日本のポイントオブケア（POC）診断市場：2025年～2033年
出版日: 2025年04月22日
発行: DataM Intelligence
ページ情報: 英文 126 Pages
納期: 即日から翌営業日
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概要

日本のポイントオブケア（POC）診断の市場規模は、2024年に8億3,204万米ドルに達し、2033年には19億2,562万米ドルに達すると予測され、予測期間の2025年～2033年のCAGRは9.8%となる見込みです。

ポイントオブケア（POC）診断とは、集中的な検査室や病院ではなく、患者の診療現場またはその近くで行われる医療診断検査プロセスを指します。これらの検査は、ヘルスケアプロバイダーが患者の診断と治療に関して迅速かつ十分な情報に基づいた意思決定を行えるよう、迅速かつ信頼性の高い結果を提供するよう設計されています。その目的は、患者が結果を待ったり、検査のために別の場所に移動したりする必要なく、即座に意思決定ができるようにすることです。

ポイントオブケア診断は、ヘルスケア専門家と患者が、医療現場またはその近くで診断検査を実施できるようにする、急速に進歩している分野です。導入と技術革新が進むにつれ、ポイントオブケア診断は、診断をより迅速に、よりアクセスしやすく、より効率的にすることで、ヘルスケア提供に変革をもたらしつつあります。

日本のポイントオブケア診断（POCD）市場成長の最も大きな促進要因の一つは、診断技術の急速な進歩です。ヘルスケアシステムがより迅速で分散化された医療へとシフトする中、技術革新はPOCDツールの精度を高め、使いやすくし、複雑化する診断業務に対応できるようにするために不可欠です。

電子工学、ロボット工学、精密工学の先進国として知られる日本は、患者の診療時点またはその近くで信頼性の高い結果を得られる小型で効率的な診断機器の開発で最先端を走ってきました。診断機器の小型化により、臨床現場でも非臨床現場でもリアルタイムのデータを提供するポータブルなハンドヘルド機器が実現した。これは、高齢化と地方の医療格差が進む日本では特に有益なことであり、病院を越えてケアを拡大できるソリューションが必要とされています。

例えば、ポータブル血液分析装置、ウェアラブル・バイオセンサー、モバイル尿検査ツールは、糖尿病や腎臓病などの慢性疾患を患者の自宅から直接モニターするためにますます使用されるようになっています。こうした技術革新により、通院回数が減り、過剰な医療施設の負担が軽減されます。例えば、2023年4月、分子診断学の世界的リーダーであるQIAGENは、SARS-CoV-2呼吸器パネルを搭載したQIAstat-Dxシンドロミック検査システムが間もなく日本で利用可能になると発表しました。

QIAstat-Dxはシンドロミック検査プラットフォームで、1検体から複数の病原体を同時に検査できるシステムです。QIAstat-DxはリアルタイムPCR技術を使用しており、迅速で正確な結果を提供します。高齢化と慢性疾患率の上昇という2つの課題に直面し続ける日本では、こうした技術開発が、国全体のヘルスケア提供の質を維持・向上させる上で極めて重要な役割を果たすことになります。

日本におけるポイントオブケア診断（POCD）市場の成長を阻害する主な要因の一つは、日本の医療機器と体外診断（IVD）に対する厳しく複雑な規制の枠組みです。日本では、POCDツールを含むすべての医療機器・診断薬は、医薬品医療機器総合機構（PMDA）の定める要件に適合し、厚生労働省の承認を受けた上で販売されなければなりません。この承認プロセスはしばしば長期にわたり、非常に詳細で、資源集約的であるため、国内外メーカーにとって市場参入はとりわけ困難です。

日本の薬事承認プロセスには、広範な臨床検証、安全性試験、文書化が含まれ、多くの場合、米国やEUのような他の世界市場で要求される基準を上回ります。このことは、国民に高品質で安全なヘルスケア製品を提供することを保証する一方で、POCD企業にとっては商品化の遅れや開発コストの増加につながります。

リソースの限られた新興企業や中小企業にとって、このような状況を乗り切ることは大きな障壁となり、イノベーションを阻害し、先端診断技術の採用を遅らせることになりかねないです。日本は規制制度を通じて高い安全性と品質を維持していますが、これらの要件の厳格さと複雑さはPOCD市場の成長にとって大きな課題となっています。

当レポートでは、日本のポイントオブケア（POC）診断市場について調査し、市場の概要とともに、製品別、技術別、用途別、エンドユーザー別、地域別動向、競合情勢、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 市場のイントロダクションと範囲

第2章 経営者の洞察と重要なポイント

第3章 市場力学

  • 影響要因
    • 促進要因
    • 抑制要因
    • 機会
    • 影響分析

第4章 戦略的洞察と業界展望

  • 市場のリーダーとパイオニア
  • CXOの視点
  • 最新の開発とブレークスルー
  • ケーススタディ/進行中の調査
  • 規制と償還の情勢
  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 特許分析
  • SWOT分析
  • アンメットニーズとギャップ
  • 市場参入と拡大のための推奨戦略
  • シナリオ分析ベストケース、ベースケース、ワーストケースの予測
  • 価格分析と価格動向
  • キーオピニオンリーダー

第5章 日本のPOC診断市場（製品別）

  • 感染症検査製品
  • 血糖値製品
  • 血液ガスおよび電解質製品
  • 尿検査製品
  • 血液検査製品
  • 妊娠・生殖検査製品
  • 腫瘍/がんプロファイリング製品
  • 乱用薬物製品
  • その他

第6章 日本のポイントオブケア診断市場（技術別）

  • ラテラルフローアッセイ
  • 免疫測定
  • 分子診断
  • マイクロ流体工学
  • その他

第7章 日本のPOC診断市場（用途別）

  • 感染症
  • 心臓病学
  • 腫瘍学
  • 内分泌学
  • 血液学
  • 神経学
  • 薬物検査
  • その他

第8章 日本のPOC診断市場（エンドユーザー別）

  • 病院と診療所
  • 診断検査室
  • 在宅ケア
  • 外来手術センター（ASC）

第9章 競合情勢と市場ポジショニング

  • 競合状況の概要と主要市場参入企業
  • 市場シェア分析とポジショニングマトリックス
  • 戦略的パートナーシップ、合併・買収
  • 製品ポートフォリオとイノベーションにおける主な発展
  • 企業ベンチマーク

第10章 企業プロファイル

  • Becton, Dickinson and Company（BD）
    • 会社概要
    • 製品ポートフォリオ
    • 財務概要
    • 主な発展
    • SWOT分析
  • Quidel Corporation
  • QIAGEN
  • Trinity Biotech
  • BioMerieux SA
  • Roche Diagnostics
  • Siemens Healthineers
  • Abbott Laboratories
  • Danaher Corporation
  • SEKISUI MEDICAL CO., LTD.

第11章 仮定と調査手法

第12章 付録

目次
Product Code: PH9493

The Japan point-of-care diagnostics market reached US$ 832.04 million in 2024 and is expected to reach US$ 1,925.62 million by 2033, growing at a CAGR of 9.8 % during the forecast period 2025-2033.

Point-of-care diagnostics refers to a medical diagnostic testing process that takes place at or near the site of patient care rather than in a centralized laboratory or hospital setting. These tests are designed to deliver rapid and reliable results that help healthcare providers make quick, informed decisions regarding patient diagnosis and treatment. The goal is to enable immediate decision-making without the need for a patient to wait for results or travel to another location for testing.

Point-of-care diagnostics is a rapidly advancing field that enables healthcare professionals and patients to perform diagnostic tests at or near the site of care. With growing adoption and innovations, point-of-care diagnostics is transforming healthcare delivery by making diagnostics faster, more accessible, and more efficient.

Market Dynamics: Drivers & Restraints

Rising Advancements in Point-of-Care Diagnostics

One of the most significant drivers of growth in Japan's point-of-care diagnostics (POCD) market is the rapid advancement in diagnostic technologies. As healthcare systems shift toward faster, more decentralized care, technological innovation has been essential in making POCD tools more accurate, user-friendly, and capable of handling increasingly complex diagnostic tasks.

Japan, known for its leadership in electronics, robotics, and precision engineering, has been at the forefront of developing compact and efficient diagnostic devices that can deliver reliable results at or near the point of patient care. The miniaturization of diagnostic equipment has allowed for portable, handheld devices that provide real-time data in both clinical and non-clinical settings. This is particularly beneficial in Japan, where an aging population and rural healthcare disparities require solutions that can extend care beyond hospitals.

For example, portable blood analyzers, wearable biosensors, and mobile urinalysis tools are increasingly used to monitor chronic diseases like diabetes and kidney conditions directly from patients' homes. These innovations reduce hospital visits and ease the burden on overstretched healthcare facilities. For instance, in April 2023, QIAGEN, a global leader in molecular diagnostics, announced that its QIAstat-Dx syndromic testing system will soon be available in Japan, featuring a SARS-CoV-2 Respiratory Panel.

QIAstat-Dx is a syndromic testing platform, a system that can simultaneously test for multiple pathogens from one patient sample. It uses real-time PCR technology to deliver fast, accurate results. As Japan continues to confront the dual challenges of an aging population and rising chronic disease rates, these technological developments will play a pivotal role in sustaining and improving the quality of healthcare delivery across the country.

Stringent Regulatory Requirements

One of the major restraints hindering the growth of the point-of-care diagnostics (POCD) market in Japan is the country's stringent and complex regulatory framework for medical devices and in vitro diagnostics (IVDs). In Japan, all medical devices and diagnostics, including POCD tools, must comply with the requirements set forth by the Pharmaceuticals and Medical Devices Agency (PMDA) and receive approval from the Ministry of Health, Labour and Welfare (MHLW) before being marketed. This approval process is often lengthy, highly detailed, and resource-intensive, making market entry particularly challenging for both domestic and foreign manufacturers.

The regulatory approval process in Japan involves extensive clinical validation, safety testing, and documentation, often exceeding the standards required in other global markets like the U.S. or the EU. While this ensures high-quality and safe healthcare products for the public, it also leads to delayed commercialization and increases the cost of development for POCD companies.

For startups or smaller players with limited resources, navigating this landscape can be a major barrier, discouraging innovation and slowing down the adoption of advanced diagnostic technologies. While Japan maintains a high standard of safety and quality through its regulatory systems, the rigidity and complexity of these requirements pose a significant challenge to the growth of the POCD market.

Segment Analysis

The Japan point-of-care diagnostics market is segmented based on product, technology, application, and end-user.

Product:

The infectious disease testing products segment in the product is expected to dominate the Japan point-of-care diagnostics market share

Infectious disease testing products play a pivotal role in the early identification and containment of infectious conditions. These diagnostic tools are specifically designed to detect pathogens such as bacteria, viruses, and other microorganisms directly from patient samples. Their use is essential for limiting the spread of contagious diseases and guiding timely medical intervention, especially within Japan's aging population and densely populated urban centers.

A wide range of products is available in the market, each tailored to detect specific infectious agents or biomarkers linked to diseases like influenza, SARS-CoV-2, Clostridium difficile, HIV, Group A streptococcus, sexually transmitted infections (STIs), and Lyme disease. Among these, rapid diagnostic tests are particularly valuable, as they deliver accurate results within minutes at or near the point of care, facilitating immediate decision-making by healthcare providers.

The performance and accessibility of these testing tools in Japan have significantly improved over recent years due to a wave of product innovations, technological advancements, and high-impact product launches. These developments are driven by the growing demand for faster, more portable, and multiplex-capable solutions that can operate in decentralized healthcare settings, such as clinics, pharmacies, and home-care environments.

The Japan point-of-care diagnostics market is witnessing significant growth, driven by the increasing need for rapid and accurate detection of infectious diseases. Key factors such as early diagnosis, the shift toward decentralized testing, and rising concerns over antimicrobial resistance are accelerating market demand. Additionally, government efforts to enhance diagnostic capabilities and preparedness, particularly in response to public health threats, are further strengthening market expansion.

Competitive Landscape

The major players in the Japan point-of-care diagnostics market include Becton, Dickinson and Company (BD), Quidel Corporation, QIAGEN, Trinity Biotech, BioMerieux SA, Roche Diagnostics, Siemens Healthineers, Abbott Laboratories, Danaher Corporation, and SEKISUI MEDICAL CO., LTD., among others.

Key Developments

  • In June 2023, Sysmex Corporation, a major Japanese diagnostics company headquartered in Kobe, launched a new rapid testing system in Europe aimed at detecting antimicrobial susceptibility, a critical tool in the fight against antimicrobial resistance.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials and product pipelines and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyze product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: This covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyze competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The Japan point-of-care diagnostics market report delivers a detailed analysis with 42 key tables, more than 45 visually impactful figures, and 126 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Application & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

Table of Contents

1. Market Introduction and Scope

  • 1.1. Objectives of the Report
  • 1.2. Report Coverage & Definitions
  • 1.3. Report Scope

2. Executive Insights and Key Takeaways

  • 2.1. Market Highlights and Strategic Takeaways
  • 2.2. Key Trends and Future Projections
  • 2.3. Snippet by Product
  • 2.4. Snippet by Technology
  • 2.5. Snippet by Application
  • 2.6. Snippet by End-User

3. Dynamics

  • 3.1. Impacting Factors
    • 3.1.1. Drivers
      • 3.1.1.1. Rising Advancements in Point-of-Care Diagnostics
      • 3.1.1.2. Rising Aging Population and Chronic Diseases
    • 3.1.2. Restraints
      • 3.1.2.1. Stringent Regulatory Requirements
      • 3.1.2.2. High Costs of Advanced Diagnostics
    • 3.1.3. Opportunity
      • 3.1.3.1. Expansion of Home-Based Testing
      • 3.1.3.2. Advancements in Digital and Mobile Health Integration
    • 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

  • 4.1. Market Leaders and Pioneers
    • 4.1.1. Emerging Pioneers and Prominent Players
    • 4.1.2. Established leaders with the largest-selling Brand
    • 4.1.3. Market leaders with established Product
  • 4.2. CXO Perspectives
  • 4.3. Latest Developments and Breakthroughs
  • 4.4. Case Studies/Ongoing Research
  • 4.5. Regulatory and Reimbursement Landscape
  • 4.6. Porter's Five Forces Analysis
  • 4.7. Supply Chain Analysis
  • 4.8. Patent Analysis
  • 4.9. SWOT Analysis
  • 4.10. Unmet Needs and Gaps
  • 4.11. Recommended Strategies for Market Entry and Expansion
  • 4.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
  • 4.13. Pricing Analysis and Price Dynamics
  • 4.14. Key Opinion Leaders

5. Japan Point-of-Care Diagnostics Market, By Product

  • 5.1. Introduction
    • 5.1.1. Analysis and Y-o-Y Growth Analysis (%), By Product
    • 5.1.2. Market Attractiveness Index, By Product
  • 5.2. Infectious Disease Testing Products*
    • 5.2.1. Introduction
    • 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 5.3. Blood Glucose Products
  • 5.4. Blood Gas & Electrolyte Products
  • 5.5. Urinalysis Products
  • 5.6. Hemoatology Testing Products
  • 5.7. Pregnancy and Fertility Testing Products
  • 5.8. Tumor/Cancer Profiling Products
  • 5.9. Drug-of-Abuse Products
  • 5.10. Others

6. Japan Point-of-Care Diagnostics Market, By Technology

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 6.1.2. Market Attractiveness Index, By Technology
  • 6.2. Lateral Flow Assays*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Immunoassays
  • 6.4. Molecular Diagnostics
  • 6.5. Microfluidics
  • 6.6. Others

7. Japan Point-of-Care Diagnostics Market, By Application

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.1.2. Market Attractiveness Index, By Application
  • 7.2. Infectious Diseases*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Cardiology
  • 7.4. Oncology
  • 7.5. Endocrinology
  • 7.6. Hematology
  • 7.7. Neurology
  • 7.8. Drug Testing
  • 7.9. Others

8. Japan Point-of-Care Diagnostics Market, By End-User

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 8.1.2. Market Attractiveness Index, By End-User
  • 8.2. Hospitals & Clinics*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Diagnostic Laboratories
  • 8.4. Home Care Settings
  • 8.5. Ambulatory Surgery Centers (ASCs)

9. Competitive Landscape and Market Positioning

  • 9.1. Competitive Overview and Key Market Players
  • 9.2. Market Share Analysis and Positioning Matrix
  • 9.3. Strategic Partnerships, Mergers & Acquisitions
  • 9.4. Key Developments in Product Portfolios and Innovations
  • 9.5. Company Benchmarking

10. Company Profiles

  • 10.1. Becton, Dickinson and Company (BD)*
    • 10.1.1. Company Overview
    • 10.1.2. Product Portfolio
      • 10.1.2.1. Product Description
      • 10.1.2.2. Product Key Performance Indicators (KPIs)
      • 10.1.2.3. Historic and Forecasted Product Sales
      • 10.1.2.4. Product Sales Volume
    • 10.1.3. Financial Overview
      • 10.1.3.1. Company Revenue
      • 10.1.3.2. Geographical Revenue Shares
      • 10.1.3.3. Revenue Forecasts
    • 10.1.4. Key Developments
      • 10.1.4.1. Mergers & Acquisitions
      • 10.1.4.2. Key Product Development Activities
      • 10.1.4.3. Regulatory Approvals, etc.
    • 10.1.5. SWOT Analysis
  • 10.2. Quidel Corporation
  • 10.3. QIAGEN
  • 10.4. Trinity Biotech
  • 10.5. BioMerieux SA
  • 10.6. Roche Diagnostics
  • 10.7. Siemens Healthineers
  • 10.8. Abbott Laboratories
  • 10.9. Danaher Corporation
  • 10.10. SEKISUI MEDICAL CO., LTD.

LIST NOT EXHAUSTIVE

11. Assumptions and Research Methodology

  • 11.1. Data Collection Methods
  • 11.2. Data Triangulation
  • 11.3. Forecasting Techniques
  • 11.4. Data Verification and Validation

12. Appendix

  • 12.1. About Us and Services
  • 12.2. Contact Us